Global Regulatory Affairs Device Lead (Associate Director)
Scorpion Therapeutics, Framingham, Massachusetts, us, 01704
Role Summary
Global Regulatory Affairs Device Lead (Associate Director) based in Morristown, NJ or Cambridge, MA or Framingham, MA. You will drive global regulatory strategies for medical device and combination products, collaborate with cross-functional teams to navigate complex regulatory landscapes, optimize product development and manufacturing processes, and influence product approvals through strategic negotiations with health authorities worldwide. The role supports a wide range of combination products, from pre-filled syringes and injectors to large volume devices, developing device strategies, conducting risk assessments, and serving as the primary liaison with regulatory authorities.
Responsibilities
Serve as GRA Device Lead on assigned project teams (early phase, late stage and marketed products)
Provide regulatory guidance and advice to Global Regulatory Team (GRT) and cross-functional teams
Develop and execute innovative and sustainable medical device regulatory strategies covering stand-alone medical devices and device parts of combination products
Define device Health Authority interactions plan, lead device related health authority interactions and support cross-functional health authority interactions
Identify medical device regulatory acceleration opportunities and regulatory risks, and propose thoughtful risk mitigations in collaboration with the GRT
Identify and manage issues and opportunities that impact submissions timelines; ensure appropriate communication, resolution and/or escalation as needed
Lead global filing and lifecycle management activities for device submissions/device aspects of medicinal product submissions
Liaises with device, clinical, manufacturing, commercial, and other internal business partners to enable successful regulatory outcomes
Prepare, review and approve design control deliverables
Contribute to product development and lifecycle management planning
Provide regulatory impact assessments for proposed product changes
May serve as a regional/local regulatory lead and point of contact with medical device Health Authorities for projects/products in their remit, as needed
Participates in the development and monitoring of the global regulatory environment and updating of standards and processes related to device regulations
Contributes to the development of a harmonized, One Sanofi regulatory voice through participation in appropriate device committees, forums
Supports operational and compliance activities for assigned deliverables, develops, executes regulatory submission planning activities, including generating submission content plans, submission tracking, communication and document management
Contribute to internal regulatory processes and procedures for medical devices
Accountable for regulatory assessment for medical devices Due Diligence activities as applicable
Qualifications
Experience: 8+ years of relevant pharmaceutical/biotechnology/medical device industry experience with 5+ years of medical device and/or combination product regulatory experience with contributions to regulatory filings and implementation of regulatory strategies; experience responding to Health Authority questions
Regulatory Expertise: Experience preparing regulatory documentation and familiarity with standard submission processes
Technical Knowledge: Understanding of clinical development of medicinal products, device/IVD development (including design controls), manufacturing processes, and regulatory requirements in major markets. Working knowledge with technical/industry standards related to medical devices. Ability to synthesize and critically analyze data from multiple sources
Collaboration Skills: Ability to work effectively in a matrix environment, engaging cross-functionally with R&D, Device, Manufacturing, and Quality teams. Demonstrates business acumen, strong leadership, influencing and persuasive negotiation skills
Soft Skills: Strategic thinking, initiative, change agent leadership and risk assessment proficiency, including ability to integrate overall business objectives into actionable project strategies
Education: Bachelor's degree in a scientific or engineering discipline. Graduate degree preferred
Communication: Strong written and verbal communication and influencing skills, with fluency in English
Adaptability: Capability to manage multiple projects in a fast-paced, hybrid work environment (60% on-site), with openness to learning and growth
Education
Bachelor's degree in a scientific or engineering discipline. Graduate degree preferred.
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Responsibilities
Serve as GRA Device Lead on assigned project teams (early phase, late stage and marketed products)
Provide regulatory guidance and advice to Global Regulatory Team (GRT) and cross-functional teams
Develop and execute innovative and sustainable medical device regulatory strategies covering stand-alone medical devices and device parts of combination products
Define device Health Authority interactions plan, lead device related health authority interactions and support cross-functional health authority interactions
Identify medical device regulatory acceleration opportunities and regulatory risks, and propose thoughtful risk mitigations in collaboration with the GRT
Identify and manage issues and opportunities that impact submissions timelines; ensure appropriate communication, resolution and/or escalation as needed
Lead global filing and lifecycle management activities for device submissions/device aspects of medicinal product submissions
Liaises with device, clinical, manufacturing, commercial, and other internal business partners to enable successful regulatory outcomes
Prepare, review and approve design control deliverables
Contribute to product development and lifecycle management planning
Provide regulatory impact assessments for proposed product changes
May serve as a regional/local regulatory lead and point of contact with medical device Health Authorities for projects/products in their remit, as needed
Participates in the development and monitoring of the global regulatory environment and updating of standards and processes related to device regulations
Contributes to the development of a harmonized, One Sanofi regulatory voice through participation in appropriate device committees, forums
Supports operational and compliance activities for assigned deliverables, develops, executes regulatory submission planning activities, including generating submission content plans, submission tracking, communication and document management
Contribute to internal regulatory processes and procedures for medical devices
Accountable for regulatory assessment for medical devices Due Diligence activities as applicable
Qualifications
Experience: 8+ years of relevant pharmaceutical/biotechnology/medical device industry experience with 5+ years of medical device and/or combination product regulatory experience with contributions to regulatory filings and implementation of regulatory strategies; experience responding to Health Authority questions
Regulatory Expertise: Experience preparing regulatory documentation and familiarity with standard submission processes
Technical Knowledge: Understanding of clinical development of medicinal products, device/IVD development (including design controls), manufacturing processes, and regulatory requirements in major markets. Working knowledge with technical/industry standards related to medical devices. Ability to synthesize and critically analyze data from multiple sources
Collaboration Skills: Ability to work effectively in a matrix environment, engaging cross-functionally with R&D, Device, Manufacturing, and Quality teams. Demonstrates business acumen, strong leadership, influencing and persuasive negotiation skills
Soft Skills: Strategic thinking, initiative, change agent leadership and risk assessment proficiency, including ability to integrate overall business objectives into actionable project strategies
Education: Bachelor's degree in a scientific or engineering discipline. Graduate degree preferred
Communication: Strong written and verbal communication and influencing skills, with fluency in English
Adaptability: Capability to manage multiple projects in a fast-paced, hybrid work environment (60% on-site), with openness to learning and growth
Education
Bachelor's degree in a scientific or engineering discipline. Graduate degree preferred.
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